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Park Plaza Amsterdam Airport

May 14, 2019 8:00 AM - May 15, 2019 5:15 PM

Melbournestraat 1, 1175 RM Lijnden, Netherlands

Regulatory Aspects in Pharmacovigilance and Practical Examples

Module 2 of the MEB/DIA Excellence in Pharmacovigilance training course covers key elements for the establishment of a quality system in Pharmacovigilance including aspects of safety reporting requirement in the clinical trial as well as post-authorisation phase.

Agenda

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 10:00 AM

SUSAR Reporting in Clinical Trials and Case Studies

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SUSAR Reporting in Clinical Trials and Case Studies continued

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:45 PM

The Role of the Qualified Person Responsible for Pharmacovigilance

1:45 PM — 2:30 PM

Preparation of Development Safety Update Reports (DSURs)

2:30 PM — 2:45 PM

COFFEE BREAK

2:45 PM — 3:30 PM

Preparation of Periodic Safety Update Reports (PSURs)

3:30 PM — 5:00 PM

Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies

5:00 PM — 5:15 PM

COFFEE BREAK

5:15 PM — 6:15 PM

Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies continued

8:30 AM — 10:15 AM

Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies continued

10:15 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

Reporting Requirements in Special Situations in the Post-authorisation Phase and Case Studies

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:45 PM

Pharmacovigilance System Master File (PSMF)

1:45 PM — 2:45 PM

MedDRA and Standardised MedDRA Queries (SMQs)

2:45 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:00 PM

Audits and Inspections in Pharmacovigilance - Regulatory Perspective

4:00 PM — 4:15 PM

COFFEE BREAK

4:15 PM — 5:15 PM

Audits and Inspections in Pharmacovigilance - Industry Perspective

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